Disposable cartridge for hypodermic syringe



March 13, 1956 F. E. BROWN DISPOSABLE CARTRIDGE FOR HYPODERMIC SYRINGE Filed Aug. 25, 1954 FIG.

IN VEN TOR. FRANK E. BRowu A 7' TORNEVS United States Patent 2,737,948 DI SPOSABLE CARTRIDGE FOR HYPODERMIC SYRINGE a Frank E. Brown, Burbank, Califl, assignor to Chas. Pfizer & Co., Inc., Brooklyn, N. Y.-, a corporation of Delaware Application August 23, 1954, Serial No. 451,353

6 Claims. (01. 122F215 This invention is a continuation in part of my copending application, Disposable Cartridge for Hyp odermic Syringe, filed January 4, 1952, and bearing 264,992. More particularly, the invention relates to an improved hypodermic syringe assembly and has especial reference to a nlovelfojrrn of apre filled, disposable'combinedneedle and ampule assemblyi'for dispensingvar-ious infedi'ca'ments.

.As indicated in said prior .copending application, various forms of pie-loaded hypodermic syringe assemblies including needle bearing cartridges containing liquid 'me'dicarnents have heretof re been devised. In :suchdevices, the cartridge normallykoniprise's a fragile glass vial or ampule containing the medicament and which i's'sealed atone en'd'by a movable rubbl'er plunger "memher and atthe otherendfb'y an immovable'but per'foinane stopper-or closure member. In accordance with theinvent'ion set fofth'in said copndingapplicaiion, the vial or .ainpul'elis adapted to support a 'coveredlor sheathed hollow hypodermic needle in firm union with the "vial and linposit'ion to be manipulated in ,a relatively simple manner to perforate the closure stopper andesta'blish communication betweenthe contents of the vial and a flesh piercing end on the needle. After use, the exhausted :assembly is discarded .in'cludiiig "the needle.

in such type assemblyfit is exceedingl difficult to maintain a substantially .sterile conditionli n the compo- *nent parts, and at .the :same'tiine, ifacilitat'efirapid me lpensive assembly "ofnthe same. Another 'difiiculty "with hypodermic syringes of this type is tlie prov'is'ion o'fian adequate and substantially :foolproof seal at .the Epu'nctiirablewend-of the'vial or ampule. As willberadily understood, :a corollary to this r problem ,is 'ithe -Qp'rovisiofnof meansfor guiding and/0r :directing the associated needle :into :the' puncturable stopper during manufacture .of the assembly and rultimately rthrough- -the stopperidiiring use of ithe'idevice in :theifield. i i 7 Accordingly, one of the principal objects of .thisinve'ntibn is to iprovide an {improved hypodermic syringe assembly at the-aforementioned :type .which .overcomes these various .Elisad vantages. .furthertobject of ithisn'nventidn iis to provide an improved cartridge .end seal. Anotliendbject of thisiinventioniis -to .-provide an improved needle nnit facilitating :rapid manufacture and :assembly off the comp'onent 'parts. ".Other objects and .advantages 'of this invention "will become apparent from .the' descriptfon and claims which follow.

1y setting forth prefer'redfforms of "the improved ;construction, and in which:

Fig. 1 is as'ect'ional view, partly .in .elevation, of a preferred embodiment of theimproved disposable 'hypoiie'r'rnic syringe cartridge assembly according r wthe f presentdnvention with f-the comp'onent partsipositioned lfor 'jassenibiing' the needle unitbn the cartridge unit.

Fig. '2 is managed sc'tional view along ethe aaxial 2,737,948 Patented Mar. 13, 1956 center line of the needle employed in the construction of Fig. 1 illustrating an improved stopper piercing end.

Fig. 3 is a perspective view illustrating a-modified form of puncture stopper for use with the cartridge assembly of Fig. 1.

Fig. 4 is a fragmentary sectional view of a modified form of needle.

Fig. 5 is a side elevation view of a modified form of closure stopper.

Fig. 6 is a fragmentary elevation view of a modified form of needle holder and cover construction.

Referring 'now to the drawings, the improved hypodermic syringe assembly of the present invention includes a cartridge'or ampule generally indicated 10, and a needle unit generally indicated 11, operably associated there,- with. As will be appreciated, the needle unit is in position to be inserted directly onto the adjacent end of the cartridge unit to bring the needle into piercing relationshipwith the closure member of the cartridge and to unite the needle and cartridge in a semi-permanentunion which will Withstand handling and the like manipulation Without causing loss of sterility.

The cartridge unit consists of an elongated, hollow glass vial or cylinder 12 Whichmay be closed at .one end (not shownjby means of a reciprocable plunger forming afhermetical seal with the internal wall of the glass cylinder in a manner known inthe art. The otherend of thecylinder includes an opening 14 which is sealed-by means of a stoppermember -20. The stopper is preferably formed of a resilient elastomeric material, such as rubber, and which iincludes an :externalradially directed flange 21 for overlapping the axial-face of an enlarged annular neck 13 .at the-open end of the cylinder. Normadly,- the diameter of the flange 21 is chosen to be identical with the diametrical extent of annular neck 13.

The stopper 20 is provided with a plurality of spaced radially directed peripheral ,fins 22 extending between flange 21 and a lower truncated nose portion '23. The stopper also includes an indentation orinwardly directed recess v25 'in -the -front -face of flange 21 :at about its geometrical center-leaving a thin wall separating the needle from the contents of the cartridge. 7

:A closure cap or hermetical seal member '30 is providedto-overlie the :face ofstopperiflange 521 and to.cornpress the same against-neck;1 3 as by crimping thevclosure cap ,behind: the iannular-neckof the vial in the manner indicated. -1Preferably, the closure .cap comprises a icylindrical, cup-like, metallic ferrule .of a non-corrosive material such as aluminum, and is :adapted'zto be :secured over-,the closurestopper 24} by spinning thezextendediperipheral edge of the ferrule into tight contact with %the reduced vialneck behind lip 13. Theferrule includesa central aperture -31iwhich'is adapted'to be aligned with the@1'-ecess;25 infthe facexofistopper 20.

The fin membersiZZ-On the closure stopper normally extend radially of the-main surface ofthe stopper'fo r-a distance between ;05 and .3 mm. and are'integral'with the mainbedy of-the stopper. Thisconstructionhas been found to be-exceedinglyeifective in facilitating insertion of theresilient and normally :hard to fnandlestopper =into the vial, the fins serving-to vent air from theivial: during insertion of the stopper, .thereby preventing -subs equent unseatingof the stopper. Thefins also assist noseportion ,23 incentrally positioningthe stopper body'within the vial opening. Moreover, fins22, upon beingbrought into contact with the internal ,wall surface ,of .the vial opening, are resiliently displaced radially inwardly :towards the center of the stopperand concomitantly force the .unribhed portions of'the stopperfradially outwardly intoya more firm frictional fit with the .vial wall. As wil l be ireadilynnderstood, :this provides. an exceedingly. effective fluid-tight seal. Additionally, provision of the fin construction compensates for manufacturing deformities such as variations in the thickness of the body portion of the stopper member and for other physical irregularities which are normally unavoidable in the mass production of items of this type.

The needle unit 11 comprises a needle holder formed as a stepped cylinder member having an axially extending sleeve-like flange or skirt 45, a cylindrical portion 46, and a reduced cylindrical forward end portion 47. The holder 40 is preferably molded of a resilient elastic material such as a polyethylene resin, although any resilient plastic, rubber-like material is suitable. Alternatively, the holder can be formed in whole or in part of a relatively hard material including metal so long as the extended axial flange or sleeve portion includes flexibility or resiliency in a direction transverse to the axis of the assembly. The axially directed sleeve 45, in effect, forms an annular skirt which is adapted to fit tightly over the ferrule 30 of the cartridge unit in sealing relationship therewith, and for which purpose the sleeve 45 must include some radial play in order to provide a firm frictional fit and yet be able to slide over the ferrule. If desired, the peripheral portion of the sleeve may be slightly flared outwardly to facilitate assembly over the ferrule 30.

The holder 40 is adapted to integrally carry a hollow hypodermic needle 60 which for this purpose includes a central perforation or passageway 41 in which the needle 60 can be imbedded in any known manner, as for example, by molding unit 40 with needle 60 in position, or by cementing needle 60 in passageway 41, or by heat treating at least a portion of the holder 40 in the region of passageway 41 to shrink fit or bond the same to the needle.

The lower reduced cylindrical end portion 47 of the holder includes a plurality of axially directed radial vents which may take the form of flattened areas, grooves or recesses 49, spaced about the periphery of the holder. These grooves or recesses merge with the forward truncated nose 48 of the holder and cooperate with a cylindrical needle cover member 50. As will be more readily understood by reference to said prior copending application, the cover member is adapted to enclose the sterile flesh piercing end 61 of needle 60, and for this purpose, is firmly mounted on the reduced cylindrical portion 47 but releasably secured thereto by means of a tight but manually movable fit, the cover 50 being adapted to he slipped off of the reduced portion by pulling it axially outwardly. Provision of the grooves or flute-like construction 49 in the lower portion of the reduced cylindrical end 47 serves to facilitate rapid removal of the cover 50 from the needle holder by allowing atmospheric air to enter the pocket 51 of the cover as the cover is being withdrawn from the holder end. While the cover is preferably applied to the needle before the needle is assembled on the cartridge, the vents on the needle holder are also advantageous in preventing entrapment of air within pocket 51 when the cover is applied subsequent to assembly of the cartridge and needle. It will be readily understood that the cover is thereby more firmly and securely mounted on end portion 47 while at the same time minimizing a possible source of contamination by reducing the amount of air entrapped in pocket 51.

In order to further assist and facilitate assembly of the complete unit in a short period of time and without incurring excessive breakage or contamination of the component parts, the needle unit is formed with a particular construction preventing a novel stopper piercing end 62. The details of this construction will be more readily appreciated by reference to Fig. 2 showing the end of such needle in an enlarged cross-sectional view. As there shown, the needle comprises a hollow, cylindrical body having a central passageway 66 for transporting medicament from one end of the needle to the other. In accordance with the present invention, the steppe;-

piercing end 62 of the needle is formed by bending, grinding or otherwise shaping one peripheral wall portion of the needle to have a curvature transversely of the axis A of the needle in the manner indicated in the drawings so that the needle point is spaced radially inwardly from the outer periphery of the needle and the side wall of the stopper recess 25. This geometric configuration can be readily obtained by simply cutting the needle on an angle and grinding the outer periphery of the leading edge. It may also be obtained to a greater degree by bending the end of the hollow stem to provide a curved wall portion 67 followed by cutting and grinding of the bent needle stem along a plane which intersects the curved surface 67 at an acute angle with the axis A of the needle to present a boundary surface 68 forming a stopper piercing point 69 which may be substantially aligned with the center line A of the needle. The angle at which boundary surface 68 is formed may vary widely but is preferably between 10 and 45 degrees. Likewise, the degree 'of curvature of wall portion 67 may vary widely. In any event, the arrangement is such that the piercing point 69 so formed is spaced radially inwardly from the outer periphery of the main needle body 60 and the side walls of the stopper recess 25.

By reason of the above described improved construction, and in cooperation with the recess 25 in the center of the stopper 20, the needle assembly 11 can be rapidly and easily moved into a firm self-supporting union with cartridge unit 10 without danger of the needle snagging in the side walls of recess 25. As reference to Fig. I will indicate, axial movement of the needle unit toward the cartridge unit will serve to bring needle 60 into proximity with the central aperture or perforation 31 in ferrule 30, and, in the event the needle is misaligned therewith, the particular configuration of the needle serves to center the needle therein and into recess 25 of the stopper. Continued movement of the needle assembly serves to seat skirt 45 on the ferrule 30 and to imbed the end 69 of the needle in the recess of the resilient stopper, the latter action taking place with the curved surface 67 of the needle serving to bulge or retract the resilient material of the stopper away from point 69. This also effectively assists the subsequent cutting action of boundary 68 and point 69 whereby a slit of substantially umform character is incised through the thin wall of the stopper body separating the needle from the contents of the cartridge without danger of occluding the passage 66 with any particles of the stopper matrix. It also has been observed that the provision of this geometric shape to the stopper piercing end of the needle materlally assists in holding the needle in axial alignment with the center of the stopper, so that the needle will emerge from the stopper at about the center of nose 23. As will be readily understood, such operation facllltates use of the flesh piercing end 61 of the needle in a more efficient manner.

A modified form of closure stopper which is similar in construction and function to the stopper 20 of Flg. 1 is illustrated in Fig. 3 of the drawings. This stopper 1s adapted to be used with the assembly of Flg. l and comprises an improvement over the stopper of Fig. 1. As shown, this improved form of stopper 1nc1udes an upper annular seating flange 121 which is provided wlth a centrally located axially directed recess (not illustrated) in a manner identical to the recess 25 1n the stopper 20. Flange 121 includes an integral depending stern portion which is sloped or truncated as at 122 to present a gradually tapering juncture between the flange and the stem. The mean diameter of portion 1 22 18 selected to be slightly larger than the opening 14 in the cartridge. Stern 120 terminates in a frusto-conrcal nose portion 123 and integrally carries axially extending, radially directed, spaced rib members 124, comprismg three in number. The ribs 124 terminate immediately above the nose portion 123 and merge with the truncated POrtion 122 in the manner-indicated in the figure. Ribs 124 are normally formed of a height lietwen 0.05 and 0.3 millimeter.

In order to increase the sealing effect of the underface 1260f flange 121, this face is'provide'd with a raised, axially directed annular rib 127 at a point substantially midway btween'the stern juncture and the peripheral edge of the fiange. This rib is preferably formed of a height between point 0.91 and 0.1 millimeter with any desired width. With this arrangement, the stopper 120, when forced through the opening 14in the neck of a cartridge 12; most effectively clbses' the opening in a hermetical seal, the flange rib 127 firmly contacting 'the faced the cartridge neck .13 in such manner as to be deformed while the truncated 'poftion 1229f the stem is compressed by firm engagement with the walls of the opening. It will thus be understood that the longitudinal ribs 124 which are depressed radially inwardly during insertion of the stopper into the cartridge are continuously resiliently urged radially outwardly into engagement with the cylindrical wall to effectively provide sumcient frictional force to off-set retraction of the stopper from the opening. This serves to retain rib 127 and juncture 122 in effective sealing engagement with the cartridge neck.

As shown in Fig. 4 of the drawings, the location of the stopper piercing point of the needle radially inwardly of the needle periphery can be obtained by grinding or shaving the inner side wall of the needle along a line inclined towards the axis of the needle. This operation can be formed by conventional grinding and/or metal cutting equipment and generally can take place in two steps. The first step involves cutting or grinding the open end of the needle at a relatively large angle to the needle axis to form a boundary surface or edge 168 corresponding to boundary surface 68 in Fig. 2. Subsequently, the needle is cut, shaved or ground along a line making a relatively small angle with the axis of the needle to form a secondary boundary surface 167 wholly contained within the width of the needle Wall 165. This second surface makes a juncture with the boundary surface 168 to provide a piercing or cutting point at 169 which is positioned internally of the exterior needle wall surface. it will be apparent that point 169 is not located close to the center line or axis of the needle, but practical experience has shown that the positioning of the point to lie within the periphery boundary of the needle wall, in cooperation with a deeply recessed cleft in the closure stopper, will serve to effectively guide the needle unit with respect to the cartridge during assembly of the device.

A further modified form of closure stopper is illustrated in Fig. 5 of the drawing. This stopper is adapted to be used interchangably in the cartridge unit of Fig. 1, and as shown comprises a cylindrical, relatively short body 220' formed with a truncated terminal end 223 and a relatively thin sealing flange 221. The body portion of the stopper is provided with three equidistant ribs or fins 224 which extend laterally from the body for a distance of between 0.5 and 0.2 millimeter. The ribs or fins merge with the flanged end of the stopper body and with the beginning of the truncated lower portion 223, the lower end of the ribs being inclined, as shown at 228, to provide a wedging function which serves to facilitate insertion of the stopper into the cartridge. The face of flange 221 also is provided with a deep needle reserving recess (not illustrated).

A particular feature of this form of closure stopper is the elimination of any necessity for employing a subsidiary sealing flange structure on the inner face of flange 221. The short length of the radial ribs of fins employed has been found to be effective in securely locking the stopper within the cartridge neck, the ribs being compressed during insertion of the stopper into the cartridge neck in such manner as to flex or bend them at about the juncture of the vertical surface 229 and the inclined surface 228. This forms a tight friction lock with the cartridge wall.

At the same time, it will be understood that the ribs perniit escape 'of gas or air from within the c'artridge'during application'of the stopper.

' Fig. 6 illustrates a further modified construction employed according to the invention As shown, the lower end 147 of the needle holder can be "provided with opposed flattenedare'as 149 in lieu of the grooved construction of Fig. 1.

The flat areas 149 can be formed in any desired manner and of ahydesired size with a minimum of expense and are as eifectiveas grooves 49 in pennit'ting air to escape from the cover member as it is being inserted over the end 147 of the holder. In addition, the small extent of areas 149 allows the cover to become more firmly seated on thehbldei' and insilres the maintenance of the sterility of the needle. Because of the more positive fit between the holder and cover provided by this form of the invention, it is preferred to provide cover 150 with raised flutes or serrations in order to facilitate easy removal of the cover. With the fluted construction, the holder can be readily slipped oil holder 140 by a single twisting motion.

As many apparently widely different embodiments of this invention may be made without departing from the spirit and scope hereof, it is to be understood that this invention is not limited, except as defined in the appended claims.

What is claimed is:

1. An improved disposable combined ampule and needle assembly for use in hypodermic syringes comprising, an ampule having an elongated hollow body member having an annular neck about an open end, a stopper sealing the open end of said body member, means sealing the other end of said body member, said stopper including a stem portion and a radially directed flange portion, said stem portion including longitudinally extending radially directed ribs, in contact with the end opening of said body member, a recess formed in substantially the center of said flange portion of said stopper on the face opposite said stem portion, a needle holder longitudinally slidably connected to said ampule and including a stepped cylindrical configuration having a reduced diameter first end portion and an enlarged di ameter axially extending tubular skirt portion at the other end, a hollow pointed needle rigidly carried by said needle holder and including a stopper piercing end and a needle cover member releasably secured to said cylindrical portion on said needle holder and hermetically sealing said needle.

2. The combination set forth in claim 1 in which said reduced diameter end portion of said holder includes axially extending radially directed grooves for admitting air from the cover during removal of said cover member from said end portion for protecting said piercing end of the needle.

3. The combination set forth in claim 1 in which the stopper piercing end of said needle includes a piercing point positioned radially inwardly from the outer periphery of the main body of said needle and formed by a curved peripheral wall of said needle joining a cutting edge formed at an angle to the axis of said needle.

4-. An improved disposable combined ampule and needle assembly for use in hypodermic syringes com prising, an ampule having an elongated hollow body member having an annular neck about an open end, a stopper sealing the open end of said body member, means sealing the other end of said body member, said stopper including a stem portion and a radially directed flange portion, said stern portion including longitudinally extending radially directed ribs, in contact with the end opening of said body member, a recess formed in substantially the center of said flange portion of said stopper on the face opposite said stern portion, a needle holder longitudinally slidably connected to said ampule and including a stepped cylindrical configuration having a 7 reduced diameter first end portion and an enlarged diameter axially extending tubular skirt portion at the other end, a hollow pointed needle rigidly carried by said needle holder and including a stopper piercing end protruding past the terminal edge of said tubular skirt portion and a flesh piercing portion extending beyond said reduced end portion, and a needle cover member releasably secured to said cylindrical portion on said needle holder and hermetically sealing said needle, a reduced diameter end portion of said holder including axially extending radially directed grooves for admitting air from the cover during removal of said cover member from said end portion for protecting said piercing end of the needle, and in which the stopper piercing end of said needle includes a piercing point positioned radially inwardly from the outer periphery of the main body of said needle and formed by a curved peripheral wall of said needle joining a cutting edge formed at an angle to the axis of said needle.

5. The combination set forth in claim 1 in which said stopper member includes a raised annular rib on the face of said radial flange adjacent said longitudinal extending ribs for cooperating with the end face of the annular neck of said body member to hermetically seal a medicament in said body member.

6. The combination set forth in claim 5 in which the said stem portion of said stopper includes a truncated section joining the said radial flange, and said longitudinal stem ribs merge with said conical section at a slight distance from said flange.

References Cited in the file of this patent UNITED STATES PATENTS 2,675,449 Dann Mar. 9, 1954 

1. AN IMPROVED DISPOSABLE COMBINED AMPULE AND NEEDLE ASSEMBLY FOR USE IN HYPODERMIC SYRINGES COMPRISING, AN AMPULE HAVING AN ELONGATED HOLLOW BODY MEMBER HAVING AN ANNULAR NECK ABOUT AN OPEN END, A STOPPER SEALING THE OPEN END OF SAID BODY MEMBER, MEANS SEALING THE OTHER END OF SAID BODY MEMBER, SAID STOPPER 